BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1961964 · Received January 15, 2011

    Report

    Report Number
    2050012-2011-00167
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS ELEVATED AT THE TIME OF THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2010. PRE-CALIBRATION AND QC PRECISION RESULTS WERE WITHIN THE SPECIFICATIONS. THE CUSTOMER WAS TO RUN COMPARISON TEST EVERY 2 HOURS. THE FSE RETURNED ON (B)(4) 2010 AND PERFORMED PRESET MODIFICATION SERVICE. THE FSE VALIDATED POST CALIBRATION AND QC PRECISION. ALL RESULTS WERE WITHIN THE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), AND CARBON DIOXIDE (CO2) RESULTS GENERATED BY UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY A DOCTOR. THE REPEAT TESTS WERE PERFORMED AND THE REPORTS WERE CORRECTED. PER THE CUSTOMER, THE PATIENTS WERE NOT TREATED BASED ON THE INCORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1